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Alzheimer`s Disease Acitretin Medication (ADAM)

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ClinicalTrials.gov Identifier: NCT01078168
Recruitment Status : Completed
First Posted : March 2, 2010
Results First Posted : February 2, 2018
Last Update Posted : February 2, 2018
Sponsor:
Collaborator:
Alzheimer Forschungsinitiative e.V. (AFI)
Information provided by (Responsible Party):
K. Lieb, Johannes Gutenberg University Mainz

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Alzheimer Disease
Interventions: Drug: Acitretin
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
University Medical Centre of the Johannes Gutenberg University, Mainz, and University Medical Centre, Rostock, May 2010 to January 2013

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
neuropsychiatric testing, general exclusion of e.g. depression or severe diseases affecting the trial

Reporting Groups
  Description
Acitretin

oral, 30 mg per day, day 1-28

Acitretin: 30mg per day from Day 1 to Day 28

Placebo

oral, day 1-28

Placebo: Placebo


Participant Flow:   Overall Study
    Acitretin   Placebo
STARTED   11   11 
COMPLETED   11   10 
NOT COMPLETED   0   1 
Physician Decision                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Acitretin

oral, 30 mg per day, day 1-28

Acitretin: 30mg per day from Day 1 to Day 28

Placebo

oral, day 1-28

Placebo: Placebo

Total Total of all reporting groups

Baseline Measures
   Acitretin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 11   10   21 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.9  (9.6)   73  (3.8)   69.33  (7.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      9  81.8%      6  60.0%      15  71.4% 
Male      2  18.2%      4  40.0%      6  28.6% 
Region of Enrollment 
[Units: Participants]
     
Germany   11   10   21 
MMSE [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 20.4  (4.2)   23.9  (4.3)   22.2  (4.5) 
[1] MMSE: Mini-Mental State Examination; can be used to systematically and thoroughly assess mental status; range: 0-30; a score of 23 or lower is indicative of cognitive impairment


  Outcome Measures

1.  Primary:   Difference in Cerebrospinal Fluid (CSF) Soluble Alpha-clevaed Amyloid Precursor Protein (APPsα) Concentration at Visit 3 Compared to Baseline   [ Time Frame: baseline and 4 weeks (visit 3) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Prof. Dr. Andreas Fellgiebel
Organization: Clinic of Psychiatry and Psychotherapy, University Medical Center JGU Mainz
phone: +49-6131-17-7363
e-mail: Andreas.Fellgiebel@unimedizin-mainz.de



Responsible Party: K. Lieb, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT01078168     History of Changes
Other Study ID Numbers: ADAM
2009-011881-27 ( EudraCT Number )
First Submitted: March 1, 2010
First Posted: March 2, 2010
Results First Submitted: March 14, 2016
Results First Posted: February 2, 2018
Last Update Posted: February 2, 2018